Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125804381 | 12580438 | 1 | I | 20160126 | 20160721 | 20160721 | PER | US-JAZZ-2016-US-001495 | JAZZ | 0.00 | F | Y | 0.00000 | 20160721 | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125804381 | 12580438 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125804381 | 12580438 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125804381 | 12580438 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125804381 | 12580438 | 4 | SS | ORENCIA | ABATACEPT | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 6 | C | Boric acid | BORIC ACID | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 7 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 8 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 9 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125804381 | 12580438 | 10 | C | DIFLUCAN | FLUCONAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125804381 | 12580438 | 12 | C | ESTRACE | ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | 0.4 MG, UNK | U | 0 | .4 | MG | TABLET | |||||||
| 125804381 | 12580438 | 15 | C | Ginger root | GINGER | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125804381 | 12580438 | 16 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 17 | C | LO LOESTRIN FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 18 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 19 | C | Melatonin | MELATONIN | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 125804381 | 12580438 | 20 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 21 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 22 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 23 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 24 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 25 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 26 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 27 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125804381 | 12580438 | 28 | C | Benefiber Plus Calcium | 2 | UNK | U | 0 | |||||||||||
| 125804381 | 12580438 | 29 | C | DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 30 | C | Mtx | METHOTREXATE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 31 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 32 | C | PREMPRO | ESTROGENS, CONJUGATEDMEDROXYPROGESTERONE ACETATE | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 33 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | ||||||||||
| 125804381 | 12580438 | 34 | C | Vitamin b-6 | PYRIDOXINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125804381 | 12580438 | 1 | Narcolepsy |
| 125804381 | 12580438 | 2 | Cataplexy |
| 125804381 | 12580438 | 4 | Product used for unknown indication |
| 125804381 | 12580438 | 5 | Product used for unknown indication |
| 125804381 | 12580438 | 6 | Product used for unknown indication |
| 125804381 | 12580438 | 7 | Product used for unknown indication |
| 125804381 | 12580438 | 8 | Product used for unknown indication |
| 125804381 | 12580438 | 9 | Product used for unknown indication |
| 125804381 | 12580438 | 10 | Product used for unknown indication |
| 125804381 | 12580438 | 11 | Product used for unknown indication |
| 125804381 | 12580438 | 12 | Product used for unknown indication |
| 125804381 | 12580438 | 13 | Product used for unknown indication |
| 125804381 | 12580438 | 15 | Product used for unknown indication |
| 125804381 | 12580438 | 16 | Product used for unknown indication |
| 125804381 | 12580438 | 17 | Product used for unknown indication |
| 125804381 | 12580438 | 18 | Product used for unknown indication |
| 125804381 | 12580438 | 20 | Product used for unknown indication |
| 125804381 | 12580438 | 21 | Product used for unknown indication |
| 125804381 | 12580438 | 22 | Product used for unknown indication |
| 125804381 | 12580438 | 23 | Product used for unknown indication |
| 125804381 | 12580438 | 24 | Product used for unknown indication |
| 125804381 | 12580438 | 25 | Product used for unknown indication |
| 125804381 | 12580438 | 26 | Product used for unknown indication |
| 125804381 | 12580438 | 27 | Product used for unknown indication |
| 125804381 | 12580438 | 28 | Product used for unknown indication |
| 125804381 | 12580438 | 29 | Product used for unknown indication |
| 125804381 | 12580438 | 30 | Product used for unknown indication |
| 125804381 | 12580438 | 31 | Product used for unknown indication |
| 125804381 | 12580438 | 32 | Product used for unknown indication |
| 125804381 | 12580438 | 33 | Product used for unknown indication |
| 125804381 | 12580438 | 34 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125804381 | 12580438 | Migraine | |
| 125804381 | 12580438 | Mouth ulceration | |
| 125804381 | 12580438 | Nausea | |
| 125804381 | 12580438 | Unevaluable event |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125804381 | 12580438 | 1 | 201008 | 2010 | 0 | |
| 125804381 | 12580438 | 3 | 2010 | 0 | ||
| 125804381 | 12580438 | 4 | 20151209 | 0 | ||
| 125804381 | 12580438 | 5 | 20161209 | 0 | ||
| 125804381 | 12580438 | 6 | 20151209 | 0 | ||
| 125804381 | 12580438 | 7 | 20151209 | 0 | ||
| 125804381 | 12580438 | 8 | 20151209 | 0 | ||
| 125804381 | 12580438 | 9 | 20151209 | 0 | ||
| 125804381 | 12580438 | 10 | 20151209 | 0 | ||
| 125804381 | 12580438 | 11 | 20151209 | 0 | ||
| 125804381 | 12580438 | 12 | 20151209 | 0 | ||
| 125804381 | 12580438 | 13 | 20151209 | 0 | ||
| 125804381 | 12580438 | 14 | 20140601 | 0 | ||
| 125804381 | 12580438 | 15 | 20151209 | 0 | ||
| 125804381 | 12580438 | 16 | 20151209 | 0 | ||
| 125804381 | 12580438 | 17 | 20151209 | 0 | ||
| 125804381 | 12580438 | 18 | 20151209 | 20160114 | 0 | |
| 125804381 | 12580438 | 20 | 20151209 | 0 | ||
| 125804381 | 12580438 | 21 | 20151209 | 0 | ||
| 125804381 | 12580438 | 22 | 20151209 | 0 | ||
| 125804381 | 12580438 | 23 | 20151209 | 0 | ||
| 125804381 | 12580438 | 24 | 20151209 | 0 | ||
| 125804381 | 12580438 | 25 | 20151209 | 0 | ||
| 125804381 | 12580438 | 26 | 20151209 | 0 | ||
| 125804381 | 12580438 | 27 | 20151209 | 0 | ||
| 125804381 | 12580438 | 28 | 20060101 | 0 | ||
| 125804381 | 12580438 | 29 | 20110101 | 0 | ||
| 125804381 | 12580438 | 30 | 20160126 | 0 | ||
| 125804381 | 12580438 | 31 | 20140101 | 0 | ||
| 125804381 | 12580438 | 32 | 20060101 | 0 | ||
| 125804381 | 12580438 | 33 | 20160126 | 0 | ||
| 125804381 | 12580438 | 34 | 20160126 | 0 |